Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID e9d28e14-b847-4915-8620-2e9fd5eb6e04
Route
TOPICAL
Published
Effective Date 2011-07-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ensulizole (2 mL) Octinoxate (7.5 mL) Octocrylene (1.9 mL) Zinc Oxide
Inactive Ingredients
Water Glycerin Safflower Isohexadecane Butyloctyl Salicylate Cyclomethicone 5 Peg-100 Stearate Glyceryl Monostearate Cetostearyl Alcohol Triethoxycaprylylsilane Trolamine Behenyl Phosphate Hyaluronate Sodium Cyclomethicone 6 Codium Tomentosum Butylated Hydroxytoluene Tocopherol Calcium Pantothenate .alpha.-bisabolol, (+/-)- Dihexadecyl Phosphate Ceteth-10 Phosphate Propylene Glycol 1,2-butanediol Trimethylolpropane Triethylhexanoate Caprylic/capric Mono/diglycerides Anisacril Guar Gum Phenoxyethanol Methylparaben Ethylparaben Propylparaben Isobutylparaben Butylparaben Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-07-21

Description

ENSULIZOLE  2.0%, OCTINOXATE  7.5%, OCTOCRYLENE  7.5%, ZINC OXIDE  1.9%

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

ENSULIZOLE  2.0%, OCTINOXATE  7.5%, OCTOCRYLENE  7.5%, ZINC OXIDE  1.9%

Uses

TO HELP MOISTURIZE, RELIEVE AND PROTECT SKIN

Warnings

FOR EXTERNAL USE ONLY

Directions

APPLY LIBERALLY ON FACE, NECK AND OTHER EXPOSED AREAS EVERY MORNING AFTER CLEANSING. PERFECT ALONE OR UNDER MAKEUP. FOR SUNSCREEN BENEFITS, APPLY PRIOR TO SUN EXPOSURE.

Label Copy

Active Ingredient

ENSULIZOLE  2.0%, OCTINOXATE  7.5%, OCTOCRYLENE  7.5%, ZINC OXIDE  1.9%

Inactive Ingredients

WATER, GLYCERIN,CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES, ISOHEXADECANE, BUTYLOCTYL SALICYLATE, CYCLOPENTASILOXANE, PEG-100 STEARATE, GLYCERYL STEARATE, CETEARYL ALCOHOL, TRIETHOXYCAPRYLSILANE, TRIETHANOLAMINE, BEHENYL ALCOHOL, SODIUM HYALURONATE, CYCLOHEXASILOXANE, CODIUM TOMENTOSUM, BHT, TOCOPHEROL, CALCIUM PENTOTHENATE, BISABOLOL, DICETYL PHOSPHATE, CETETH-10 PHOSPHATE, PROPYLENE GLYCOL, BUTYLENE GLYCOL, TRIMETHYLOLPROPANE TRIETHYLHEXANOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SODIUM ACRYLATES COPOLYMER, XANTHAN GUM, PHENOXYETHANOL, METHYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, ISOBUTYLPARABEN, BUTYLPARABEN, IRON OXIDES

Questions Or Comments

1-866-695-3030

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

Keep Out of Reach of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL IMMEDIATELY

Stop Using This Product and Ask Doctor If

IF IRRITATION OR REDNESS DEVELOPS AND LASTS


Structured Label Content

Uses (USES)

TO HELP MOISTURIZE, RELIEVE AND PROTECT SKIN

Purpose (PURPOSE)

SUNSCREEN

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

Directions (DIRECTIONS)

APPLY LIBERALLY ON FACE, NECK AND OTHER EXPOSED AREAS EVERY MORNING AFTER CLEANSING. PERFECT ALONE OR UNDER MAKEUP. FOR SUNSCREEN BENEFITS, APPLY PRIOR TO SUN EXPOSURE.

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

ENSULIZOLE  2.0%, OCTINOXATE  7.5%, OCTOCRYLENE  7.5%, ZINC OXIDE  1.9%

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER, GLYCERIN,CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES, ISOHEXADECANE, BUTYLOCTYL SALICYLATE, CYCLOPENTASILOXANE, PEG-100 STEARATE, GLYCERYL STEARATE, CETEARYL ALCOHOL, TRIETHOXYCAPRYLSILANE, TRIETHANOLAMINE, BEHENYL ALCOHOL, SODIUM HYALURONATE, CYCLOHEXASILOXANE, CODIUM TOMENTOSUM, BHT, TOCOPHEROL, CALCIUM PENTOTHENATE, BISABOLOL, DICETYL PHOSPHATE, CETETH-10 PHOSPHATE, PROPYLENE GLYCOL, BUTYLENE GLYCOL, TRIMETHYLOLPROPANE TRIETHYLHEXANOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SODIUM ACRYLATES COPOLYMER, XANTHAN GUM, PHENOXYETHANOL, METHYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, ISOBUTYLPARABEN, BUTYLPARABEN, IRON OXIDES

Questions Or Comments (QUESTIONS OR COMMENTS)

1-866-695-3030

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL IMMEDIATELY

Stop Using This Product and Ask Doctor If (STOP USING THIS PRODUCT AND ASK DOCTOR IF)

IF IRRITATION OR REDNESS DEVELOPS AND LASTS


Advanced Ingredient Data


Raw Label Data

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